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Premature ending of the study due to difficulties obtaining a suitable placebo-inhaler. (July 2021)

Background: 10% of infants are prescribed short-acting bronchodilators for wheezing per year, yet evidence to support this treatment in children younger than two years old is scarce.

Research question: What is the (cost-)effectiveness of salbutamol inhalations (4x200µg for 7 days) versus placebo in children aged 6-24 months presenting to their primary care physician with wheezing?

Study design, setting and population: A primary care based, randomized, placebo-controlled, multicentre, parallel group trial in 40 general practices and community paediatric practices in Belgium and the Netherlands. Children will be eligible when they are otherwise healthy, aged 6-24 months, and present with physician-diagnosed wheeze and a baseline respiratory symptom score of at least 7 out of 18.

Intervention: salbutamol inhalation 4x200ug for 7 days or inhalation of placebo.

 

Outcome measures: The primary outcome is the course of the mean parent reported respiratory symptom score over 5 days. Secondary outcomes include [a] time to recovery (recovery defined as a respiratory symptom score of 5 or lower indicating only trivial symptoms), and adverse effects over the duration to the intervention (1 week), [b] healthcare utilisation, and cost-effectiveness (4 weeks), and [c] the proportion of infants with persistent wheezing on auscultation at day 5 (included as objective outcome measure).

 

Methods

At baseline, demographics and clinical features will be recorded. During 14 days, parents will record the respiratory symptom score, medication use, side-effects and days off work. At day 5, a study nurse (or medical student) follow-up visit takes place to record lung sounds of the child using a digital stethoscope. Recordings will be assessed by a panel for wheeze. After 1 month, healthcare utilisation will be extracted from the child’s electronic medical records.

 

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